The U.S. Food and Drug Administration (FDA) is close to pulling the trigger on an electronic medical device reporting system (eMDR) for post-market safety tracking of adverse events. The proposed device rule, published in the Federal Register on Aug. 21, would not change the types of incidents that the agency requires be reported, but rather would mandate that the incidents be reported in an electronic format that the FDA can process, review and archive.
For years, FDA officials have complained about drowning in paperwork and a lack of up-to-date technology. They seem to be catching up on the technology side, and now they want the industry to follow suit.
The new rules would “improve the agency’s ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems,” said David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA’s Center for Devices and Radiological Health.
“Information obtained from these reports may be critical to future action that improves patient safety.”
However, the rule would save industry $3.2 million a year and would save the FDA $1.25 million in operating costs yearly, according to the agency. In addition to the patient safety benefits, FDA officials said the move would eliminate its transcription errors, as well as the time and costs associated with receiving paper reports and transcribing data to an electronic format. The agency also said the conversion would expedite its access to safety information in a format that supports data analysis and reviews, in addition to enhancing its ability to rapidly communicate information about suspected problems to the industry, healthcare providers, consumers and government agencies.
Manufacturers, importers and user facilities would load eMDRs into the FDA’s Manufacturer and User Facility Device Experience database—or MAUDE as the agency calls it. The system provides a choice of two electronic options for reporting post-market safety information. Small manufacturers with a limited number of reports may prefer an application known as eSub, which runs on free software available from the FDA. Large firms, which often submit hundreds of reports per year, may be better off using a batch submission protocol based on a widely recognized informatics standard, according to the FDA. The proposal does not apply to reports submitted on a voluntary basis. The FDA will accept comments for 90 days before the final rule is published. The new rules become effective one year after the final version is released in the Federal Register.
“Though the FDA has been equipped to accept reports electronically for several years, few companies have made the switch to electronic systems for submission as the process is materially different in both technology and process, which has resulted in apprehension,” Mike Jovanis, vice president of product management for Sparta Systems—a provider of enterprise quality management software based in Holmdel, N.J.—told Medical Product Outsourcing. He said the proposal gives companies a firm deadline to upgrade their systems.
According to Jovanis, one of the benefits—as the FDA insists—is that eMDR eliminates the current “error-prone” manual paper process of submitting data.
“We have seen significant ROI [return on investment] in a number of our early implementations. This ROI stems from the elimination of paper, shipping/courier costs and getting rid of resource-intensive manual steps, which results in a reduction of full-time employees to manage the revised eMDR process,” he said.
Jovanis noted that the industry has been expecting eMDR regulation for some time, “but the lack of a clear mandate placed the switch to electronic submission fairly low on companies’ priority lists.”
He added: “Forward-thinking organizations have been preparing for the switch by proactively investing in enterprise-wide quality systems to streamline collection and submission processes. Organizations that are proactive in embracing technology have been the lead users in the adoption of the new electronic standard. Those that are more apprehensive about technology have taken a more conservative wait-and-see approach.”
Ultimately, this mandate should be considered an opportunity, Jovanis said. “The efficiency gains that will result will help to offset much or all of the cost involved in the implementation process for those leveraging proven, out-of-the-box solutions,” he expained. “For some organizations, legacy outdated complaint handling solutions may have to be replaced with more modern quality management solutions to achieve the benefits from a streamlined eMDR implementation.”